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Clinical Study of Propranolol Combined With Neoadjuvant Chemotherapy in Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04005365
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : November 26, 2019
Sponsor:
Collaborator:
Xiangya Hospital of Central South University
Information provided by (Responsible Party):
Yijing He, Central South University

Brief Summary:
At the cellular and animal level, we found that propranolol can inhibit the proliferation and invasion of gastric cancer cells. Further, we want to explore the efficacy and safety of propranolol in the treatment of gastric cancer patients.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Propranolol Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Propranolol Combined With Neoadjuvant Chemotherapy in Stage III-IV Gastric Cancer: an Open-lable, Single-arm Study
Actual Study Start Date : November 20, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Prop+neochemo Drug: Propranolol
add propranolol in gastric cancer patients who need to receive preoperate chemotherapy




Primary Outcome Measures :
  1. ORR [ Time Frame: Preoperative assessment ]
    CR+PR



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must provide written informed consent.
  2. age 18 to 75;Confirmed as a primary gastric adenocarcinoma patient by imaging and histology or cytology;
  3. Patients with advanced gastrointestinal cancer who have received no prior chemotherapy or radiotherapy for malignant tumors;
  4. Patients with Eastern Cooperative Oncology Group Performance Status of 0 or 1.
  5. Patients with a life expectancy of at least three months.;
  6. Organ function and hematopoietic function must meet the following requirements: hemoglobin (HGB) ≥ 90g / L; white blood cell count (WBC) ≥ 3 × 10 ^ 9 / L; absolute neutrophil count (ANC) ≥ 1.5 × 10 ^ 9 / L Platelet count (PLT) ≥ 100 × 10 ^ 9 / L; total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase ( ALT)≤2.5×ULN; if abnormal liver function is due to tumor liver metastasis, AST or ALT≤5×ULN; serum creatinine (Cr)≤1.5×ULN; international normalized ratio (INR) or plasma prothrombin time ( PT) ≤ 1.5 × ULN.
  7. Systolic blood pressure 90-140mmHg, diastolic blood pressure 60-90mmHg, heart rate 60-100bpm.
  8. No previous cardiovascular and cerebrovascular diseases, and exclusion of atrioventricular block by 24-hour ambulatory electrocardiography;
  9. subjects must agree to take effective contraceptive measures between the subject and the partner after signing the informed consent, during the study period and within 5 months after the last dose.

Exclusion Criteria:

  1. There are clinical symptoms or diseases of the heart that are not well controlled, such as uncontrolled high blood pressure, unstable angina, or myocardial infarction within 6 months prior to enrollment, or poorly controlled arrhythmias (including QTc ( men ≥ 450ms , female ≥ 470ms, QTc interval calculated by Fridericia formula), cardiogenic shock, heart block (II-III degree atrioventricular block), severe or acute heart failure, sinus bradycardia, need continuous oxygen Treated severe respiratory diseases;
  2. Subjects with symptomatic autoimmune diseases [such as, but not limited to, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, decreased thyroid function; The tester has vitiligo or has completely relieved asthma in childhood, and can be included without any intervention after adulthood; asthma that requires bronchodilators for medical intervention cannot be included]
  3. Patients with other malignant tumors within 5 years prior to enrollment, in addition to appropriate treatment of cervical carcinoma in situ, cured skin basal cell carcinoma;
  4. Immunodeficiency, such as a patient with HIV infection or other acquired, congenital immunodeficiency disease, or a history of organ transplantation
  5. Patients with active tuberculosis infection by medical history or CT examination, or a history of active tuberculosis infection within 1 year prior to enrollment, or patients with a history of active tuberculosis infection more than 1 year without formal treatment;
  6. Patients with tumor brain metastasis and bone marrow metastasis
  7. Patients who participated in other drug clinical studies within 4 weeks;
  8. Patients with history of hypersensitivity to any drugs in this study;
  9. Identified as neurological or psychiatric disorders, such as epilepsy, dementia, poor compliance;
  10. Alcohol abuse, drug abuse in the past year;
  11. Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA (HBV DNA) > 10 ^ 3 copies / mL, or hepatitis C virus antibody positive; syphilis positive;
  12. Subjects had active infection or unexplained fever >38.5 degrees during Screening period before the first dose (according to the researcher, the subject can be enrolled due to fever generated by the tumor.);
  13. Clinical symptoms of ascites or pleural effusion, requiring therapeutic puncture or drainage;
  14. Female patients who are pregnant or lactating, or planning to become pregnant or lactating;
  15. Other patients who are considered to be unsuitable for this study by the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005365


Locations
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China, Hunan
Xiangya Hospital Central South University Recruiting
Changsha, Hunan, China, 410008
Contact: Yijing He, MD, PhD    +86-15874812612    yijinghe@gmail.com   
Sponsors and Collaborators
Yijing He
Xiangya Hospital of Central South University
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Responsible Party: Yijing He, Associate Professor, Central South University
ClinicalTrials.gov Identifier: NCT04005365    
Other Study ID Numbers: 2019/prop/GC/CSU
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Yijing He, Central South University:
propranolol
gastric cancer
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents